Abstract

Supplemental melatonin has shown promise in treating sleep onset insomnia in children with autism spectrum disorders (ASD). Twenty-four children, free of psychotropic medications, completed an open-label dose-escalation study to assess dose–response, tolerability, safety, feasibility of collecting actigraphy data, and ability of outcome measures to detect change during a 14-week intervention. Supplemental melatonin improved sleep latency, as measured by actigraphy, in most children at 1 or 3 mg dosages. It was effective in week 1 of treatment, maintained effects over several months, was well tolerated and safe, and showed improvement in sleep, behavior, and parenting stress. Our findings contribute to the growing literature on supplemental melatonin for insomnia in ASD and inform planning for a large randomized trial in this population.

Notes

Acknowledgments

This work was supported by NICHD (RO1 HD59253), Autism Speaks, Vanderbilt General Clinical Research Center (M01 RR-00095 from the National Center for Research Resources, National Institutes of Health), and by the Vanderbilt University Kennedy Center (NICHD HD15052). Natrol®, (Chatsworth, CA) provided study drug but no other support. Dr. Shlomo Shinnar provided valuable input into the study design and Dr. Gregory Barnes served as the medical safety monitor. We acknowledge Ms. Kyla Surdyka and Ms. Meg Touvelle for their assistance with data entry, and are appreciative to the families who participated in this project.